An observational study in Gastrointestinal Disease, Constipation and Intolerance; Nutritional, sponsored by Ayancık State Hospital. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-10.
Sponsored by Ayancık State Hospital · Observational
Gastrointestinal (GI) motility disorders in intensive care patients remain relatively unexplored. Nowadays, the frequency, risk factors and complications of GI dysfunction during enteral nutrition (EN) become more questionable. Our aim is to evaluate the frequency, risk factors and complications of GI dysfunction during EN in the first 2 weeks of the intensive care unit (ICU) stay and to identify precautions to prevent the development of GI dysfunction and avoid complications.
Critical illness is typically associated with a catabolic stress state in which patients demonstrate a systemic inflammatory response coupled with complications of increased infectious morbidity, multiple organ dysfunction, prolonged hospitalization, and disproportionate mortality. Suspension of feeding and the resultant inability to reach nutritional goals is one complication of gastrointestinal (GI) dysfunction, but there are others (mucosal barrier disruption, altered motility, atrophy of the mucosa, and reduced mass of gut-associated lymphoid tissue) that may explain the greater length of stay (LOS) and death rate with GI dysfunction. In Europe and the United States, nutritional administration guidelines recommend primarily enteral nutrition (EN) for hemodynamically stable intensive care unit (ICU) patients. Providing EN in these patients has been shown to be superior to parenteral nutrition. GI complications such as constipation, delayed gastric emptying, diarrhea, and vomiting may occur in up to 50% of mechanically ventilated patients and adversely affect ICU mortality and LOS. Nevertheless, there is no consensus for obtaining a precise assessment of GI function.Diagnosis of GI dysfunction in ICU patients is complex and relies on clinical symptoms. Lack of validated markers of GI system dysfunction is often misdiagnosed and poorly managed in the ICU. The role of nutrition in critical illness is important, but there is an increasing evidence and broadening consensus that aggressive early feeding as well as prolonged underfeeding both should be avoided. Avoidance of complications like malnutrition, aspiration of gastric contents, wound infections, and decubitus through GI dysfunction is an important part of management of patients with GI failure.
628 studies on the registry are indexed under Gastrointestinal Diseases; 128 are open to participants now.
This study's enrollment of 137 is below the median of 325 across 190 observational studies indexed under Gastrointestinal Diseases.
Browse Gastrointestinal Diseases studies →Ayancık State Hospital is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
In this prospective observational study, 137 out of 226 patients consecutively admitted into a mixed medical-surgical ICU from 1 January 2015 to 31 June 2015 were enrolled.
Older than 18 years old. Stay longer than 48 hours at ICU.
Exclusion Criteria:
Has enterostomy/colostomy or diagnosis of GI bleeding. Prone position. Laxative drug use. Clostridium Difficile infection positivity.
Patients who had GI dysfunction (Group I) for one or more occasions.
Other: MDR bacteria positivity · Other: negative fluid balance
Patients who had normal GI function (Group II) for one or more occasions.
Other: MDR bacteria positivity · Other: negative fluid balance
A total of 137 patients who received nasogastric tube feeding in an ICU of a tertiary hospital were enrolled.
A total of 137 patients who received nasogastric tube feeding in an ICU of a tertiary hospital were enrolled.
The incidence of GI dysfunction
Constipation, diarrhea, UDI
Time frame: up to 14 days.
The sequential organ failure assessment(SOFA) score
SOFA Score is a mortality pre-score that is based on the degree of dysfunction of six organ systems. Each organ system is assigned a point value from 0 (normal)to 4 (high degree of dysfunction/failure). The SOFA score ranges from 0 to 24.The highest SOFA score correlates with highest mortality rates. Scores of more than 11 corresponded to mortality of more than 80%.
Time frame: at admission.
Hypoalbuminemia
below 2,5 g/dl
Time frame: up to 14 days.
Catecholamine use
mcg
Time frame: up to 14 days.
Length of hospital stay
days
Time frame: through study completion, which is 6 months time period.
No study locations are listed for this record.
Plan to share: Undecided
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Ayancık State Hospital